ALL DOCUMENTS ARE WRITTEN USING MS WORD OR EXCEL. THEY CARRY NO ADVERTS AND ARE 100% EDITABLE. TO SEARCH AND FIND A DOCUMENT TEMPLATE - FIRST SELECT THE APPROPRIATE SECTION FROM THE LIST BELOW - ONCE IN THAT SECTION - CLICK "Control f". THIS WILL OPEN A TEXT BOX AT THE BOTTOM LEFT OF THIS SCREEN. TYPE INTO THIS BOX - DOCUMENT TITLE OR PART OF IT, AND CLICK ON "Next" THIS WILL FIND TITLE AND STEP YOU THROUGH SIMILAR TITLES. WHEN YOU PURCHASE A DOCUMENT FROM THIS SITE YOU WILL AUTOMATICALLY BE SENT A URL LINK TO DOWNLOAD YOUR DOCUMENT. THESE URL LINKS ARE AROUND 130 CHARACTERS LONG AND IT IS ESSENTIAL THEY ARE NOT BROKEN.

Validation Online; is part of the AKC group which has over fifty years experience of QA & QC Implementation tasks and ten years of direct internet documentation sales.

This Matrix must sit along side your VMP or PVP and together with these documents give a very concise overall picture of your validation program. This four part matrix allows you to list all the equipment and systems that must be qualified. Each entry is allocated a row in the matrix. The row consists of eleven headings, these may be edited as required (but come with all the standard documentation titles inserted). In this matrix there is room to enter the document number, prefixed by, A to D. The document number gives you the instant cross reference to the current document, the A to D prefix shows the progress stage.

Please remember that this document is an Excel document, so when your download link arrives you must use Excel to open it

Quantity

Combined IQ-OQ-PQ Computer (Issue-4) $159.0010000003

It has been carefully designed to make it the preferred choice in all branches of the industry for the qualification of computers used in embedded / management / Control / Supervisory / Recording roles. It is a very popular 64 page document that can be swiftly and simply edited down for smaller systems or scaled up for larger systems.
The IQ section establishes documented verification that key aspects of the computer adhere to approved design intentions and that the recommendations of the regulators have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the computer performance in its normal operating environment is consistently as specified in the URS.

Package Computer Validation Level-2. (Issue 3) $610.0010000590In this chain of regulatory required validation documentation for the validation of a computer system, the VMP has been omitted. This package is targeted at any system that does not required a dedicated VMP to be raised. The Validation Package contains one of each of these documents: VP, URS, DQ, VRA, IQ, OQ, PQ.
Quantity

Computer Validation Master Plan (Issue 5.) $115.0010000600

The Computer Validation Master Plan, is the starting point for validation, and hence the most important validation document. It improves validation efficiency greatly by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is an expected document with the FDA, and a mandated document with the EU.
While in the past computer validation was more focused on functions of single user computer systems, recently the focus has progressed into network infrastructure, networked systems and on security, authenticity and integrity of data acquired and evaluated by computer systems.
However never forget that a piece of equipment is purchased and used, for a purpose, and that purpose is set out in the purchaserís User Requirements Specification (URS). Therefore the first and foremost requirement for any piece of equipment, is the verification that it satisfies the requirements specified in this URS.

Document
Statistics

Protocols
= 1

Pages
= 47

Paragraphs
= 945

Lines
= 1801

Words
= 9922

Characters
= 66311

Graphics
= 15

Size = 789
KB

Quantity

CSV Validation Plan (Issue 3.) $89.0010000605

This document follows Validation Online's standard method of using a fully detailed and interactive generic document and enabling to use the attached SOP to quickly convert this generic document into a first class company bespoke document. This CSV VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.

Document
Statistics

Protocols
= 1

Pages
= 29

Paragraphs
= 688

Lines
= 1332

Words
= 5571

Characters
= 36210

Graphics
= 12

Size = 303
KB

Quantity

Computer User Requirements Specification (Issue 5.) $115.0010000620

The document that sets the standard, and specifies your computer requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of CURS, CURS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or driven systems.

Quantity

CSV Design Qualification (Issue 3.) $89.0010000622

The Standard Operating Procedure attached to this generic computer design qualification protocol, will chapter by chapter take you through the task of raising a fully detailed protocol. The main body is split into fourteen tables, each one probing the computer design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these computer design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that youíre DQís are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.

Document
Statistics

Protocols
= 1

Pages = 29

Paragraphs
= 634

Lines
= 1961

Words
= 3142

Characters
= 19475

Graphics
= 19

Size = 316
KB

Quantity

CSV Installation Qualification (Issue 6.) $115.0010000640

Installation Qualification (IQ) is an important step in the overall validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements. GAMP 4, is used as a general guide, however there are some areas where it is better to stick with the FDA interpretations.
Validation Online has extensive validation experience, where we know that there is a regulatory sensitive area we make absolutely certain that our documentation is clear, concise and supplies the information the regulators are anticipating. These protocols have evolved over 15 years use in the pharmaceutical and allied industries.

Document
Statistics

Protocols
= 1

Pages
= 51

Paragraphs
= 1030

Lines
= 3240

Words
= 6006

Characters
= 38541

Graphics
= 39

Size
= 581KB

Quantity

CSV Operational Qualification (Issue 6.) $115.0010000680

Operational Qualification (OQ) is an important step in the overall validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements, progressively and simply. GAMP 4, is used as a general guide, however there are some areas where we find it preferable to stick with the FDA interpretations.
Validation Online has extensive validation experience, where we have found over the years, on the regulatory debriefs, that there are certain presentations that they prefer, we have always been quick to comply. Just as with the IQ, this OQ has evolved over 15 years and countless regulatory reviews.

Document
Statistics

Protocols
= 1

Pages
= 40

Paragraphs
= 664

Lines
= 2291

Words
= 4571

Characters
= 28586

Graphics
= 23

Size = 397
KB

Quantity

Software Validation SOP (Issue-2) $22.0010000700

This Standard Operating Procedure (SOP) takes you through the validation process for software, from the very early first stages to the final closing stage. It will ensure that your validation is seamless, that the correct documents are raised, approved, executed, reviewed and accepted correctly. It shows how to use validation tools such as the very important matrix control document and equally important software risk assessments.
There are ever-increasing demands on the Biotechnology and Pharmaceutical industries to meet increasing regulatory and legislative requirements, whilst improving the performance and efficiency of the business. This SOP shows the way to streamline your validation while still being fully compliant. Easing and smoothing the production and flow of protocols, so decreasing costs and delivering validation ahead of schedule.
It is essential material for the new comer to validation and will direct you flawlessly through all validation tasks. For the company it is an essential SOP to add to the library. For your convenience it is written in word.

Quantity

Computer Performance Qualification (Issue 7.) $87.0010000720

The Computer Performance Qualification is the culmination of the validation process. The protocol is used in conjunction with the system operating SOP, to verify that the system process is consistent and correct. The results of the testing must be recorder and reviewed with a view to ensuring that the deviancies (within permitted tolerances) that exist are random and not a trend that will lead to out of specification operation during production use.

Quantity

DCS Installation Qualification (Issue 6.) $115.0010000750

Installation Qualification of the DCS will confirm that; The title and version of the software is documented. The software has been loaded correctly. Specific site hardware items have been installed correctly. Power supplies, earth connections, and field connections are correct and enable the system to power up. Control and monitoring instrumentation are installed and have been calibrated. System functions operate on power up, and any built in diagnostics are satisfactory. Product contact material is acceptable. Drawing, documents, specification are all in place. 4.4 Electrical Conformance Verification (Minor). System Future Maintenance. Change & Consumable Parts.

Test sheet used in the operational qualification protocol to document and record whether the equipment produces data that necessitates compliance with 21 CFR Part 11. This document is included in the standard OQ, but available separately here.

Quantity

21 CFR Part 11, Verification (Issue 3.) $26.0011000164

This test script has been designed to verify whether a system or a specific piece of equipment conforms with the requirements detailed in Part11. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.

Quantity

Analog Address Verification (Issue 3.) $16.0011000165

Analog Loop address verification. This confirms and documents that that the computer input specified in the system specification of the loop is correct. A mandatory part of system validation. This document is included in the standard IQ, but available separately here.

Quantity

Analog Loop Tests (Issue 3.) $16.0011000166

Analog Loop testing. This confirms and documents the integrity of the entire loop, and is a mandatory part of validation of system. Only available here as a paste in addendum to the Installation Qualification.

Test sheet used in the operational qualification protocol to document and record the issue level, date of issue and title of the application software that the equipment under qualification has installed during execution of this operational qualification. This document is included in the standard OQ, but available separately here.

Quantity

System Drawing Verification (Issue 2.) $16.0011000172

Test sheets used in Installation Qualification Protocol to verify that the engineering drawings are as required in 21 CFR. Comes with standard IQ, but available separately here.

Quantity

Electrical Conformance Verification (minor) (Issue 3.) $16.0011000173

Test sheets used in Installation Qualification Protocol to verify that the system electrical installation conforms to good industry standards. Comes with standard IQ, but available separately here.

Quantity

Input Output Address Verification (Issue 3.) $16.0011000176

Input output address verification is mandatory, and is executed to document and verify that the computer input output address configurations is in accordance with the drawing specifications. Only available here as a paste in addendum to the Installation Qualification.

Quantity

Power failure Test (Issue 3.) $16.0011000180

Test sheet used in the operational qualification protocol to document and verify that when the equipment is subjected to an unintentional loss of electric supply it will fail and be reinstated in a manner save to the product and operating personnel. This document is included in the standard OQ, but available separately here.

Quantity

Operating System Software Verification (Issue 3.) $16.0011000183Test sheet used in operational qualification to document and record system operating software titles and issue level that were in used during OQ execution. Included in standard OQ, but available separately here.
Quantity

Radio Frequency InterferenceVerification (Issue 5.) $16.0011000185

Test sheet used in the operational qualification protocol to document and verify that when the operation of equipment will not be adversely affected by the use, near by, of radio emitting devices. This document is included in the standard OQ, but available separately here.

Quantity

Safety/Health/Environmental Assessments (Issue 2.) $16.0011000187

There are several Health, Safety and Environmental assessments that must be carried before an item of equipment is put into service. This test script ensures that they are all in place and available for review. This document is not included in the standard operational qualification, but is a available here as a direct download.

Quantity

Security of Back-up Software (Issue 3.) $16.0011000188

It is mandatory that where software has to be validated, there is a certified true copy, of that software stored in conditions laid down by cGMP's. This test script verifies that these conditions are being met. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.

Quantity

Sensor Calibration Verification (Issue 3.) $16.0011000189

Test sheets used in Installation Qualification Protocol to verify that all system sensors requirements as detailed in 21 CFR, are complied with, comes with standard IQ, but available separately here.

Quantity

Software Quality Verification (Issue 3.) $16.0011000190

Test script used in operational qualification to document and record system operating software titles and issue level that were in used during OQ execution. Not Included in standard OQ, but available separately here.

Quantity

System Component Verification (Issue 2.) $16.0011000191

Test sheets used in Installation Qualification Protocol to verify that the system components are installed correctly and that the installation is documented as detailed in 21 CFR. Comes with standard IQ, but available separately here.

Quantity

System Documentation (SOP) Verification (Issue 3.) $16.0011000192

Test sheet used in operational qualification to verify that all the SOP requirements in CFR 21 for this type of equipment are in place and are approved company documents. Included in the standard OQ, but available separately here.

Quantity

System Documentation Verification (Issue 3.) $16.0011000193

Test sheets used in Installation Qualification Protocol to verify that the equipment documentation is as required in 21 CFR. Comes with standard IQ, but available separately here.

Quantity

System Future Maintenance Verification (Issue 3.) $16.0011000194

Test sheets used in Installation Qualification Protocol to verify that post qualifiction maintenance of system is adequate and complies with 21 CFR requirements. Comes with standard IQ, but available separately here.

Quantity

Test Equipment Calibration Verification (Issue 6.) $16.0011000195

Test sheet used in the operational qualification protocol to document and verify that all test equipment and sensors used in the execution of the operation qualification are calibrated, and have traceable calibration standards. This document is included in the standard OQ, but available separately here.

Quantity

Verification of Password Controlled Access (Issue 2.) $16.0011000197

It is required to verify in this test script that access to the equipment is controlled by the use of passwords, and that the passwords are graded to allow access only for their authorized job functions. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.